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Medical Writer II

2 months ago

Billerica, United States PAREXEL Full time

Medical Writer II

Location: Home Based from the continental US (East Coast Region)

Parexelis one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are currently looking for:

As aParexel Medical Writer II you will be exposed to different project teams,therapies and devices, aswell as a diverseportfolio of clients. The ability to understand our clients' needs and achieve quality results is critical for us to continue to be one of the best clinical research organizations (CROs) in the world. To accomplish this, we believe that you must have the abilityto work independently as well as collaboratively every day.

Our writers are an integral part of clinical teams that support our clients worldwide and they assist those teams in writing and coordinating successful documentation across a wide range of therapeutic areas. Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as the primary client contact.

Skills

  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to consistently produce documents of high quality.
  • Demonstrates attention to details and proactivity.
  • Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
  • A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
  • Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
  • Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Possesses team leadership skills and cross-cultural sensitivity.
  • Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
  • Strives to understand and satisfy client needs.
  • Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.


Knowledge and Experience:

  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Extensive clinical/scientific writing skills, specifically study protocols, model informed consents, interim and final clinical study reports, and safety update reports.
  • Scientific background essential; writing experience includes multiple clinical study reports.
  • Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.

Education:

  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
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